Clearance Summary
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT received FDA 510(k) clearance under submission number K972005, sponsored by Reaads Medical Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1997-08-13.
- Submission: K972005
- Applicant / Sponsor: Reaads Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7290
- Decision date: 1997-08-13
Classification & Regulation
This clearance is catalogued under FDA product code GGP and 21 CFR 864.7290, within the Hematology review panel as a Class II device.